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What is itraconazole?

Itraconazole is an antifungal antibiotic.

Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

Itraconazole may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about itraconazole?

Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Nizoral), if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment.

Other drugs that should not be taken together with itraconazole include astemizole (Hismanal), or levomethadyl Orlaam) (these drugs are no longer available in the U.S.).

There are many other medicines that can interact with itraconazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before taking itraconazole, tell your doctor if you have heart disease, a history of stroke, a heart rhythm disorder, kidney or liver disease, a breathing disorder, cystic fibrosis, or a history of "Long QT syndrome."

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medication at the pharmacy and ask the pharmacist if you have any questions. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Call your doctor if your symptoms do not improve.

What should I discuss with my healthcare provider before taking itraconazole?

Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Nizoral), if you have ever had congestive heart failure, or if you are pregnant or planning to become pregnant during treatment. The following drugs should not be taken together with itraconazole:

If you have any of these conditions, you may need a dose adjustment or special tests to safely take itraconazole.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Itraconazole passes into breast milk and can harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take itraconazole?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

The itraconazole tablet should be taken after a full meal. Take itraconazole oral solution (liquid) on an empty stomach, at least 1 hour before or 2 hours after a meal. Swish the liquid in your mouth for several seconds before swallowing it.

Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medication at the pharmacy and ask the pharmacist if you have any questions. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Call your doctor if your symptoms do not improve.

To be sure this medication is not causing harmful effects, your liver function may need to be checked with blood tests on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of an itraconazole overdose are not known.

What should I avoid while taking itraconazole?

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) within 1 hour before or 2 hours after you take itraconazole. These medications can make it harder for your body to absorb itraconazole.

Itraconazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Itraconazole Dosing Information

Usual Adult Dose for Blastomycosis:

IV: 200 mg via IV infusion (administered over 1 hour) twice a day for 4 doses, followed by 200 mg once a dayThe safety and efficacy of IV itraconazole use exceeding 14 days is unknown.

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose may be increased in 100 mg increments to a maximum of 400 mg/day

Doses greater than 200 mg/day should be given in 2 divided doses.

Total itraconazole therapy (IV infusion followed by capsules) should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided. Some clinicians recommend therapy for at least 12 months for disseminated or chronic pulmonary histoplasmosis and 6 to 12 months for blastomycosis.

Usual Adult Dose for Histoplasmosis:

IV: 200 mg via IV infusion (administered over 1 hour) twice a day for 4 doses, followed by 200 mg once a dayThe safety and efficacy of IV itraconazole use exceeding 14 days is unknown.

Capsules: 200 mg orally once a day; if no obvious improvement or if evidence of progressive fungal disease, the dose may be increased in 100 mg increments to a maximum of 400 mg/day

Doses greater than 200 mg/day should be given in 2 divided doses.

Total itraconazole therapy (IV infusion followed by capsules) should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided. Some clinicians recommend therapy for at least 12 months for disseminated or chronic pulmonary histoplasmosis and 6 to 12 months for blastomycosis.

Usual Adult Dose for Febrile Neutropenia:

Empiric Therapy in Febrile, Neutropenic Patients with Suspected Fungal Infections (ETFN): 200 mg via IV infusion (administered over 1 hour) twice a day for 4 doses, followed by 200 mg once a day for up to 14 days

Treatment should be continued with 200 mg of itraconazole oral solution administered twice a day until resolution of clinically significant neutropenia.

The safety and efficacy of itraconazole use exceeding 28 days in ETFN is unknown.

Usual Adult Dose for Aspergillosis -- Aspergilloma:

IV: 200 mg via IV infusion (administered over 1 hour) twice a day for 4 doses, followed by 200 mg once a dayThe safety and efficacy of IV itraconazole use exceeding 14 days is unknown.

Capsules: 200 to 400 mg orally per day in one or two divided doses

Total itraconazole therapy (IV infusion followed by capsules) should be continued for a minimum of 3 months and until clinical parameters and laboratory tests indicate the active fungal infection has subsided.

Usual Adult Dose for Onychomycosis -- Toenail:

Toenails with or without fingernail involvement:Capsules: 200 mg orally once a day for 12 weeks

Usual Adult Dose for Oral Thrush:

Oral solution:Oropharyngeal candidiasis: 200 mg orally once a day for 1 to 2 weeks

Clinical signs and symptoms of oropharyngeal candidiasis generally resolve within several days. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Clinical response will be seen in 2 to 4 weeks in patients responding to therapy. Patients may be expected to relapse shortly after discontinuing therapy.

Usual Adult Dose for Esophageal Candidiasis:

Oral solution: 100 mg orally once a day for a minimum of 3 weeksTreatment should continue for 2 weeks following resolution of symptoms. Doses up to 200 mg/day may be used.

Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

Usual Adult Dose for Onychomycosis -- Fingernail:

Fingernails only:Capsules: 200 mg orally twice a day for 1 week; the dosing should be repeated after 3 weeks without itraconazole for a total of 2 treatment pulses

Usual Adult Dose for Candida Urinary Tract Infection:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/dayTherapy should be continued for 1 to 2 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Candidemia:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/dayTherapy should be continued for 1 to 2 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Coccidioidomycosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/dayTherapy should be continued for at least 6 months and until tests indicate fungal infection has subsided.

Usual Adult Dose for Paracoccidioidomycosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/dayTherapy should be continued for at least 6 months and until tests indicate fungal infection has subsided.

Usual Adult Dose for Dermatophytosis:

200 mg orally once a day; may be increased in 100 mg increments to 400 mg/dayTherapy should be continued for at least 4 weeks and until tests indicate fungal infection has subsided.

Usual Adult Dose for Sporotrichosis:

Capsules:Cutaneous or lymphonodular infection: 100 to 200 mg orally once a dayOsteoarticular or pulmonary infection: 200 mg to 300 mg orally 2 times a day

Usual Adult Dose for Cryptococcosis:

Capsules: 200 to 400 mg orally each dayDoses greater than 200 mg daily should be given in divided doses. The 400 mg/day dose is recommended for more severe infection and infection with central nervous system involvement in an HIV-infected patient.

Usual Adult Dose for Tinea Versicolor:

Capsules: 200 mg orally 2 times a day

Usual Adult Dose for Vaginal Candidiasis:

Capsules: 200 mg orally 2 times a day for 1 day

Usual Pediatric Dose for Histoplasmosis:

HIV-infected infants and children:Prophylaxis for first episode: 2 to 5 mg/kg orally every 12 to 24 hoursProphylaxis for recurrence: 2 to 5 mg/kg orally every 12 to 48 hours

This list is not complete and there are many other medicines that can interact with itraconazole.

Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about itraconazole.

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